Levetiracetam (Keppra®) Disease area studied Abbreviated title Phase Study ID Registry database Study results Plain language summary Publication (if available) Epilepsy A Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age Phase 3 EP0100 Completed NCT033400642021-003372-13 LINKLINK Epilepsy A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures. Phase 3 N01009 Completed NCT001758902004-000199-14 LINK PDF PDF Pina-Garza et al. Epilepsia;2009;50(5);1141-1149. Epilepsy Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method Phase 3 N01020 Completed NCT00160615 LINK PDF "Yagi, K., J Japan Epilepsy Society;2-10-2012;29;3;441-454 [In Japanese] " Epilepsy S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy Phase 4 N01031 Completed NCT00630968 PDF Steinhoff et al. Epilepsy Res;2007;76(1);6-14. Epilepsy Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy Phase 4 N01033 Completed NCT00643500 PDF Salas-Puig et al. Rev Neurol;2004;16-30;38;1117–1122. [in Spanish] Epilepsy A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy Phase 4 N01035 Completed NCT00631150 PDF Epilepsy Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy Phase 4 N01036 Completed NCT00160654 LINK PDF Kwan et al. Epilepsy Behav;2010;18(1-2);100-105. Epilepsy Trial to Evaluate the Safety and Efficacy of Keppra After Conversion to Mono-therapy in Subjects With Partial Epilepsy Phase 4 N01037 Completed NCT00630357 PDF Epilepsy Pharmacokinetic Study of Levetiracetam in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old Phase 2 N01052 Completed NCT00544050 PDF Glauser et al. Epilepsia;2007;48(6);1117-1122. Epilepsy Study to Evaluate the Safety and Efficacy of Levetiracetam in Patients Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic Seizures Phase 3 N01057 Completed NCT00160550 PDF PDF Berkovic et al. Neurology;2007;69(18);1751-1760. Epilepsy Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy Phase 3 N01061 Completed NCT00150735 PDF PDF Brodie et al. Neurology;2007;68(6);402-408. Epilepsy Determine Effects of Adjunctive Levetiracetam on Sleep Architecture in Adults With Partial Onset Epilepsy. Phase 4 N01085 Completed NCT00245713 PDF Anxiety Disorder Study to Assess the Efficacy and Safety of Levetiracetam for the Treatment of Social Anxiety Disorder (Generalized Type) Phase 2 N01086 Completed NCT00612859 PDF "Stein, M. B. et al., Journal of Clinical Psychiatry;2010;71;5;627-631 " Postherpetic Neuralgia A 16 Week Study Evaluating Levetiracetam in the Treatment of Post Herpetic Neuralgia (PHN) Phase 2 N01087 Completed NCT00160511 PDF Epilepsy Study on Safety and Efficacy of Levetiracetam in the Adjunctive Treatment of Female Subjects With C1 Catamenial Epilepsy Phase 4 N01088 Completed NCT00630630 PDF Epilepsy Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy. Phase 3 N01093 Completed NCT00150787 PDF Sethi et al. Neurology;2007;69(9);937-938. Epilepsy Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With Epilepsy Phase 3 N01099 Completed NCT00160628 PDF Heo et al. Seizure;2007;16(5);402-409. Epilepsy Double-blind, Placebo-controlled Study of Levetiracetam in Adults With POS Phase 3 N01102 Completed NCT00152373 PDF Wu et al. Epilepsia;2009;50(3);398-405. Epilepsy A 19-week Cognition Study of Levetiracetam in Children With Partial Onset Seizures Phase 2 N01103 Completed NCT001050402014-004396-23 LINK PDF PDF Levisohn et al. Epilepsia;2009;50(11);2377-2389. Parkinson's Disease Levetiracetam Treatment in Adult Subjects With Parkinson's Disease Experiencing Troublesome Dyskinesias Phase 2 N01105 Completed NCT00160576 PDF "Ferreira, J. Eur J Neurol;2004;11;Suppl 2;331 8th Congress of the European Federation of Neurological Societies (EFNS), September 4-7, 2004;Paris, France " Epilepsy Monotherapy With Levetiracetam in Patients Suffering From Epilepsy. Phase 3 N01127 Completed NCT00150813 LINK PDF Tardive Dyskinesia Levetiracetam in the Treatment of Neuroleptic-induced Tardive Dyskinesia Phase 2 N01142 Completed NCT001759552004-001302-27 PDF Epilepsy Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures Phase 3 N01148 Completed NCT001525162004-000200-40 LINKLINK PDF Schiemann-Delgado et al.J Child Neurol;2012;27(1);80-89. Epilepsy A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures Except Partial Seizures Evolving to Secondarily Generalized Seizures) Phase 3 N01159 Completed NCT012287472014-004401-32 LINKLINK PDF Wu L., et al. Epilepsia Open 2018; 3(4):474–84 Epilepsy Safety and Tolerability of Levetiracetam Intravenous 15 Minute Infusion in Subjects Suffering From Partial Onset Seizures Phase 2 N01166 Completed NCT00610454 PDF Baulac et al. Epilepsia;2007;48(3);589-592. Epilepsy Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy Phase 3 N01175 Completed NCT001759032004-001339-41 LINK PDF "Trinka et al. J Neurol Neurosurg Psychiatry;2013;84(10);1138-1147 Pohlmann-Eden, B., et al. BMC Neurol;2016;16;1;149." Epilepsy A Double-blind Confirmatory Trial of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures Phase 3 N01221 Completed NCT002806962014-004333-57 LINK PDF PDF Inoue, Y. et al., Psychiatry Clin Neurosci;2015;69;10;640-648 Epilepsy A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures Phase 3 N01222 Completed NCT003674322014-004334-26 LINKLINK "Yagi, K., Japan J Clin Psychopharm;2016;19;1027-1040 [In Japanese] " Epilepsy An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures Phase 3 N01223 Completed NCT010637642014-004335-39 LINKLINK Nakamura et al. Brain Nerve;2013;65(9);1083-1092. [in Japanese] Epilepsy A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR Phase 3 N01235 Completed NCT003680692006-000987-10 LINKLINK Peltola et al. Epilepsia;2009;50(3);406-414. Epilepsy Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903). Phase 3 N01237 Completed NCT002916552006-000173-29 LINKLINK Epilepsy Cross Sectional Study to Evaluate the Acceptability of Oral Solution of Levetiracetam Phase 4 N01242 Completed NCT00319605 Matías-Guíu et al. Methods Find Exp Clin Pharmacol;2010;32(7);507-516. Epilepsy Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy Phase 2 N01274 Completed NCT005353922006-005722-23 LINKLINK PDF "Weinstock et al. J Child Neurol;2013;28(11);1423-1429. " Epilepsy Open-label Study of Levetiracetam Intravenous Infusion in Children (1 Month-4 Years Old) With Epilepsy Phase 2 N01275 Completed NCT005059342007-003517-13 LINKLINK PDF Weinstock et al. J Child Neurol;2013;28(11);1423-1429. Epilepsy Conversion to Monotherapy Study With Keppra XR for Partial Seizures Phase 3 N01280 Completed NCT004190942007-000897-21 LINKLINK Chung,S. et al. Epilepsy Res;2012;101(1-2);92-102. Epilepsy Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures Phase 3 N01281 Completed NCT004193932007-000899-17 LINKLINK Chung, S., et al. Epilepsy Res;2016;120;7-12 Epilepsy Study Evaluating the Pharmacokinetics of Keppra Extended Release (XR) in Children and Adults With Epilepsy Phase 2 N01340 Completed NCT009614412014-004376-39 LINKLINK "Naritoku et al. Epilepsy Curr;2010;11;1 Suppl. 1. 64th Annual Meeting of the American Epilepsy Society (AES), December 3-7, 2010;San Antonio, USA." Epilepsy Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures Phase 4 N01353 Completed NCT012297352014-004402-15 LINKLINK Lee S.K., et al. Epilepsy Behav 2019; 97:67–74 Epilepsy An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures Phase 3 N01361 Completed NCT013989562016-002879-96 LINKLINK Yagi K et al. Japan J Clin Psychopharm. 2018;21:1609-1622 [In Japanese] Epilepsy A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures Phase 3 N01363 Completed NCT012928372014-004382-25 LINKLINK "Ohtsuka, Y. et al Japan J Clin Psychopharm;2016;19;3;347-359 [in Japanese]" Epilepsy Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures Phase 3 N01364 Completed NCT019541212015-004586-84 LINKLINK PDF Liao W., et al. J Child Neurol 2020; 33(5) [In Chinese] Epilepsy Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subject With Partial Epilepsy Phase 4 N01367 Completed NCT014988222014-002713-32 LINKLINK "Kim, J. H. et al Epilepsia;2017;58;4;e70-e74 " not applicable (pharmacokinetics study) Pharmacokinetic (PK) Study in Japanese Non-epileptic Renal Impaired Patients Phase 4 N01373 Completed NCT01491113 LINK Yamamoto, J. et al., Clin Drug Investig;2014;34;11;819-828 Epilepsy An Open Label Study of Levetiracetam Monotherapy in Newly Diagnosed Epilepsy With Partial Onset Seizure Phase 3 N01375 Completed NCT015068822014-004377-16 LINKLINK PDF Kaneko, S. et al. ,J Japan Epilepsy Society;2015;32;3;519-532 [ In Japanese] Epilepsy An Open Label Study of L059 Intravenous (IV) in Japanese Epilepsy Subjects With Partial Onset Seizures Phase 2 N01378 Completed NCT01407523 LINK PDF Inoue, Y. et al., Jpn J Clin Psychopharmacol;2014;17;413-422 [In Japanese] Epilepsy A study to learn if levetiracetam reduced seizures in participants with epilepsy Phase 3 N051 Completed PDF Boon P., et al. Epilepsy Res 2002; 48(1-2):77–89 Epilepsy A study to learn if levetiracetam works in participants with epilepsy who are taking their usual anti-seizure medicines Phase 3 N132 Completed PDF Cereghino J.J. et al. Neurology 2000; 55(2):236–42 Epilepsy A study to learn if levetiracetam reduced seizures in participants with epilepsy Phase 3 N138 Completed PDF Ben-Menachem E., et al. Epilepsia 2000; 41(10):1276–83 Epilepsy A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy Phase 3 N157 Completed NCT00150709 LINK PDF " Glauser et al. Epilepsia;2005;46;Suppl 6;102. 26th International Epilepsy Congress (IEC), August 28-September 1, 2005;Paris, France. " Epilepsy Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures Phase 3 N159 Completed NCT00615615 PDF PDF Glauser et al. Neurology;2006;66(11);1654-1660. Epilepsy A Safety and Efficacy Follow-up Study With Levetiracetam in Children (4-17 Years Old) Suffering From Absence Seizures Phase 2 N164 Completed NCT00545012 PDF Epilepsy Bridging Study of L059 (Levetiracetam) in Patients With Epilepsy by Double Blind Method Phase 2 N165 Completed NCT00600509 PDF PDF Yagi, K. et al., J Japan Epilepsy Society;7-5-2010;28;1;3-16 [In Japanese] Epilepsy Levetiracetam as add-on Treatment of Myoclonic Jerks in Adolescents + Adults Phase 3 N166 Completed NCT00150774 PDF "Noachtar et al. Neurology;2-19-2008;70;8;607-616 Rosenfeld et al. Epilepsy Res;2009;85(1);72-80. " Epilepsy Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy Phase 3 N167 Completed NCT001507482004-001997-13 LINKPDF Delanty et al. Epilepsia;2012;53(1);111-119.
